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Quality Assurance Lead (GDP & SC, Launch & Trade Compliance)

Zug, Switzerland

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Quality Assurance Lead (GDP & SC, Launch & Trade Compliance)

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Job ID SR0038882 Date posted 08/12/2019 Location Zug, Switzerland

Join us as a Quality Assurance Lead (GDP & SC, Launch & Trade Compliance) in our offices in Zurich - Opfikon, Switzerland.

OVERVIEW

The Key Accountabilities of the Quality Assurance Lead (GDP & SC, Launch & Trade Compliance) –include, but are not limited to:

  • Provide leadership guidance and COE expertise to the Takeda global network on supply chain and distribution quality ensuring inspection and launch readiness for Takeda
  • Provide leadership guidance and COE expertise to the Takeda global network (Global Supply Chain (GSC), Global Manufacturing Sites (GMS), Regional Distribution Centers (RDC’s), Global Quality (GQ), LOC, and Takeda project teams) on supply chain and distribution quality topics
  • Develop and support the implementation of global quality standards relating to Controlled Substance, Trade Compliance (Import/Export), and Customer/Distributor Markets across the network
  • Drive improvements and consistency in the quality management of Supply Chain and distribution and logistics processes
  • Collaborate with respective parties to ensure supply /inventory management and identification of potential drug shortages and Product Lifecycle management (including divestments).
  • Collaborate with respective parties to ensure GDP requirements are met for inspection readiness and Launch Readiness for Global Supply Chain.
  • Maintain overview of all programs running within Commercial Quality area and report regularly to the line manager and key stakeholders as needed.

DIMENSIONS & ASPECTS

Technical/Functional (Line) Expertise

  • Strong knowledge of Global regulations and requirements governing GDP, licensing, imports/ex-ports, controlled drug/substance compliance, and other relevant supply chain activities
  • Familiarity with different supply chain & distribution models, and associated quality oversight de-sign requirements
  • In-depth understanding of end-to-end supply chain processes

Leadership

  • Ability to collaborate and partner well at all levels, globally, regionally, & cross-functionally
  • Ability to lead effectively through directing change, as well as driving change through influence
  • Ability to lead effectively an international team, leveraging on expertise available across the net-work

Decision-making and Autonomy

  • Solves problems whilst maintaining Takeda Quality Standards
  • Understands total potential impact and contributes significantly to the solution of simple or complex issues
  • Uses experience to facilitate troubleshooting, and to tackle non-routine work and projects independently
  • Offers constructive comments and proposes improvements and rationalizations to systems, policies and procedures
  • Uses own judgement to assess what to refer upwards and what to manage independently

Interaction

  • Key interactions with Global Supply Chain organization (Supply Chain Planning and Launch Management), BUs/Commercial and numerous stakeholder groups in Quality (OpU quality, Plant and Regional Quality, External Supply Quality, LOC QA) for alignment and implementation of global supply chain quality initiatives and projects including launches, controlled substances, and import/export.

Innovation 

  • A strong grasp of industry trends and emerging regulations; leverages innovation and benchmarking of industry best practices in supply chain & distribution quality to advance the GQ Roadmap

Complexity

  • Multiple countries and business units, complex mix of supply & distribution models, multiple regulatory frameworks and a wide diversity of products

EDUCATION, BEHAVIOURAL COMPETENCIES & REQUIRED SKILLS

  • Scientific degree (BSc, MSc)
  • >8 years of experience in the biotechnology and/or pharmaceutical industry, preferably both
  • Strong knowledge of regulations governing pharmaceutical supply chain and distribution.
  • Strong knowledge of controlled substance management
  • Strong interpersonal skills including excellent communications; adept at influencing and negotiating to lead formal and informal teams in a global environment.
  • Fluent in written and spoken English.
  • Working in a multinational organization effectively navigating differing regional expectations and regulations

OTHER REQUIREMENTS

  • International Travel will be required to facilitate robust partnerships and execution. Depending on growth of organization and the primary work location, travel is estimated to be between 15% and 20%.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com

What Takeda Can Offer You

To further support and inspire our employees, our benefits include: Competitive basic salary, Annual Bonus, Long Term Incentive Plan, Contributory Pension Scheme, Private Health Cover and Life Assurance.

Empowering Our People to Shine

Learn more at takedajobs.com

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.



Job ID SR0038882

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